Procurement extraction bag

ABSTRACT

There is disclosed a method of procuring allograft tissue. In an embodiment, the method includes inserting an allograft through an opening into a procurement extraction container, sealing the opening, adding extraction fluid through a second opening, agitating the fluid, collecting the fluid for detection of contamination, and sealing the second opening. There is disclosed a procurement extraction container. In one embodiment, the container includes a wall defining an interior to receive the allograft, an opening into the interior, sized to receive the allograft, a closure device for the opening, the closure device providing a hermetic seal, a second opening providing a second passageway into the interior, the second opening having a connector interface and a second closure device providing a hermetic seal so as to provide, with the first closure and the at least one wall, a sterile barrier. Other embodiments are also disclosed.

REFERENCE TO PENDING PRIOR PATENT APPLICATION

This application claims the benefit under 35 U.S.C. 120 of U.S. patentapplication Ser. No. 13/428,203, filed Mar. 23, 2012 by Jan Zajdowicz,et al. for “PROCUREMENT EXTRACTION BAG,” which patent application ishereby incorporated herein by reference.

BACKGROUND

Generally, allograft tissue is swab tested during collection todetermine bioburden presence. Typically, swabs are inoculated into aliquid growth medium to determine “growth” or “no growth.” Thus, swabsare utilized to “qualitatively” show microorganism presence. Bioburdenrelates to the degree of microbial contamination or microbial load,i.e., the number of microorganisms contaminating an object. Aftercontact with a swab during swab testing, the allograft tissue is placedin a procurement bag or other suitable container to prevent futurecontamination of the allograft tissue. The swab is preserved for futuretesting. However, swab testing merely tests a surface of the allografttissue. Swabs are generally swabbed across the entire allograft surface;however, the sensitivity of the swab is poor. Other testing proceduresare typically too difficult to carry out during the procurement process.Lack of equipment, cost of equipment, skill required to operateequipment, and size of equipment for other types of bioburden leveltesting force many technicians to utilize straightforward swab testingrather than other testing techniques.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key aspects oressential aspects of the claimed subject matter. Moreover, this Summaryis not intended for use as an aid in determining the scope of theclaimed subject matter.

In an embodiment, there is provided a method of procuring an allografttissue, the method comprising inserting an allograft tissue through afirst opening into a procurement extraction container; sealing the firstopening of the procurement extraction container; adding an extractionfluid from an extraction solution bottle through a second opening intothe procurement extraction container; agitating the extraction fluidwithin the procurement extraction container; collecting the extractionfluid into the extraction solution bottle from the procurementextraction container for detection of contamination; and sealing thesecond opening of the procurement extraction container.

In another embodiment, there is provided a procurement extractioncontainer for procuring an allograft tissue and detection ofcontamination in the allograft tissue, the procurement extractioncontainer comprising at least one wall defining an interior sized toreceive an allograft tissue; a first opening providing a firstpassageway between the interior and an external environment, the firstopening sized to receive therethrough the allograft tissue from theexternal environment into the interior; a first closure device inoperable connection with the first opening, the first closure deviceproviding a hermetic seal at the first opening so as to provide, withthe at least one wall, a sterile barrier for procurement of theallograft tissue disposed within the interior; a second openingproviding a second passageway between the interior and the externalenvironment, and the second opening having a connector interface; and asecond closure device in operable connection with the connectorinterface of the second opening, the second closure device providing ahermetic seal at the second opening so as to provide, with the firstclosure and the at least one wall, the sterile barrier for procurementof the allograft tissue disposed within the interior.

In yet another embodiment, there is provided a kit for procurement of anallograft tissue, the kit comprising an extraction solution bottlehaving screw threads and a selectively removable cap having screwthreads corresponding to the screw threads of the extraction solutionbottle; a procurement extraction container comprising at least one walldefining an interior sized to receive an allograft tissue; a firstopening providing a first passageway between the interior and anexternal environment, the first opening sized to receive therethroughthe allograft tissue from the external environment into the interior; afirst closure device in operable connection with the first opening, thefirst closure device providing a hermetic seal at the first opening soas to provide, with the at least one wall, a sterile barrier forprocurement of the allograft tissue disposed within the interior; asecond opening providing a second passageway between the interior andthe external environment, and the second opening having a connectorinterface; and a second closure device in operable connection with theconnector interface of the second opening, the second closure deviceproviding a hermetic seal at the second opening so as to provide, withthe first closure and the at least one wall, the sterile barrier forprocurement of the allograft tissue disposed within the interior;extraction fluid initially disposed in the extraction fluid bottle;wherein the extraction solution bottle and the procurement extractioncontainer selectively connect with one another to form a fluidconnection with a hermetic seal with one another to provide theextraction fluid to the procurement extraction container andsubsequently receive the extraction fluid from the container aftercontacting the allograft tissue disposed within the procurementextraction container; and wherein each of the extraction solution bottleand the procurement extraction container provide the sterile barrier forprocurement of the extraction fluid and the allograft tissue,respectively.

Other embodiments are also disclosed.

Additional objects, advantages and novel features of the technology willbe set forth in part in the description which follows, and in part willbecome more apparent to those skilled in the art upon examination of thefollowing, or may be learned from practice of the technology.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention,including the preferred embodiment, are described with reference to thefollowing figures, wherein like reference numerals refer to like partsthroughout the various views unless otherwise specified. Illustrativeembodiments of the invention are illustrated in the drawings, in which:

FIG. 1 illustrates a procurement extraction bag or container includingan allograft bone;

FIG. 2 illustrates an exemplary embodiment of an extraction solutionbottle; and

FIG. 3 illustrates another exemplary embodiment of an extractionsolution bottle having a flexible retainer extending between a screw capand a threaded connection to the bottle.

DETAILED DESCRIPTION

Embodiments are described more fully below in sufficient detail toenable those skilled in the art to practice the system and method.However, embodiments may be implemented in many different forms andshould not be construed as being limited to the embodiments set forthherein. The following detailed description is, therefore, not to betaken in a limiting sense.

In an embodiment, there is provided a method of procuring an allografttissue. One method may include inserting an allograft tissue through afirst opening into a procurement extraction container. The method mayfurther include sealing the first opening of the procurement extractioncontainer. The method may include adding an extraction fluid from anextraction solution bottle through a second opening into the procurementextraction container. The method may include the step of agitating theextraction fluid within the procurement extraction container. The methodmay include collecting the extraction fluid into the extraction solutionbottle from the procurement extraction container for detection ofcontamination. The method may include the step of sealing the secondopening of the procurement extraction container.

In one embodiment, the step of sealing the first opening includesforming a resealable seal with a zip-lock closure. In an embodiment, thestep of sealing the first opening may include forming a non-resealableseal with a glue bar so as to provide a one-time closure. In anotherembodiment, the step of sealing the first opening may include forming aseal with a zip-lock closure and subsequently forming a non-resealableseal with a glue bar so as to provide a one-time closure.

In an embodiment, the step of adding the extraction fluid includesattaching the procurement extraction container and the extractionsolution bottle to one another to form a hermetically sealed passagewayso as to provide movement of the extraction fluid in a controlled mannerbetween the extraction solution bottle and the procurement extractioncontainer.

The step of agitating the extraction fluid may include shaking theprocurement extraction container so as to liberate bioburden into theextraction fluid. Agitation may also include other mixing or movementinducing actions, e.g., squeezing, rolling, or other suitable actions.

The step of collecting the extraction fluid may include inverting theprocurement extraction container to direct the extraction fluid into theextraction solution bottle. The step of collecting the extraction fluidmay also include attaching a screw cap to the extraction solution bottlefor transportation prior to detection of contamination.

The extraction solution bottle may be sealed with the extraction fluidand sent to a testing laboratory. The sealed bag with the allograft maybe sent to a tissue bank. This minimizes the amount of time and effortneeded to process the allograft and provides testing based on a testinitiated at collection.

The step of sealing the second opening may include attaching a screw capon the procurement extraction container.

With general reference to FIGS. 1 and 2, and in an embodiment, aprocurement extraction container 5 may be provided for procuring anallograft tissue 10 and detection of contamination in the allografttissue 10. The procurement extraction container 5 may include at leastone wall 15 defining an interior 20 sized to receive the allografttissue 10. A first opening 25 in the container 5 provides a firstpassageway 30 between the interior 20 and an external environment 25.The first opening 25 may be sized to receive therethrough the allografttissue 10 from the external environment 35 into the interior 20. A firstclosure device 40 may be in operable connection with the first opening25. The first closure device 40 may provide a hermetic seal at the firstopening 40. This provides, with the wall 15 (or walls 15), a sterilebarrier for procurement of the allograft tissue 10 disposed within theinterior 20.

A second opening 45 provides a second passageway 50 between the interior20 and the external environment 35. The second opening 45 may have aconnector interface 55.

A second closure device 60 may be in operable connection with theconnector interface 55 of the second opening 45. The second closuredevice 60 may provide a hermetic seal at the second opening 45. Thisprovides, with the first closure 40 and the wall 15 (or walls 15), thesterile barrier for procurement of the allograft tissue 10 disposedwithin the interior 20.

In an embodiment, the connector interface 55 may include screw threadsrotatably engageable with a bottle 65 containing an extraction fluid.The connector interface 55 may be rotatably engageable with the secondclosure device 60. In one embodiment, the second closure device 60 is ascrew cap.

In an embodiment, the wall 15 (or walls 15) may include a flexible sheetof material. In one embodiment, the flexible sheet of material forms aplastic bag.

In an embodiment, the first closure device 40 includes a zip-lockclosure 40A. In another embodiment, the first closure 40 includes a gluebar 40B. In one embodiment, the glue bar 40B includes a non-resealableglue so as to provide a one-time closure. With this configuration, thewall 15 must be cut or the first closure 40 must be destructively openedto access the allograft tissue 10. This preserves the state of thebioburden on the allograft tissue 10 as tested with the extractionfluid. In another embodiment, the first closure 40 may include both azip-lock closure 40A and a glue bar 40B together with one another.

The connector interface 55 of the second opening 45 may be a portconfigured for selective connection with an existing extraction solutionbottle 65 (see FIG. 2.)

In an embodiment, the interior 20 is sized to receive the allografttissue 10, which is a bone, together with a suitable volume ofextraction fluid 75 to allow a non-destructive extraction test to detectcontamination of the allograft tissue 10.

In one embodiment, the interior 20 is sized to receive the allografttissue 10, which is a soft tissue graft, together with a suitable volumeof extraction fluid 75 to allow a non-destructive extraction test todetect contamination of the allograft tissue 10.

Referring again to FIGS. 1 and 2, a kit may be provided for procurementof an allograft tissue. The kit may include the extraction solutionbottle 65 having screw threads and a selectively removable cap 70 havingscrew threads corresponding to the screw threads of the extractionsolution bottle 65. The kit may also include the procurement extractioncontainer 5. The kit may include extraction fluid 75 initially disposedin the extraction fluid bottle 65. The extraction solution bottle 65 andthe procurement extraction container 5 may selectively connect with oneanother to form a fluid connection with a hermetic seal with one anotherto provide the extraction fluid 75 to the procurement extractioncontainer 5 and subsequently receive the extraction fluid 75 from thecontainer 5 after contacting the allograft tissue 10 disposed within theprocurement extraction container 5. Each of the extraction solutionbottle 65 and the procurement extraction container 5 provide the sterilebarrier for procurement of the extraction fluid 75 and the allografttissue 10, respectively.

In one embodiment, the procurement extraction container 5 is a flexiblebag, which may be wrapped around the extraction solution bottle 65 priorto insertion on the extraction bottle 65, prior to insertion of theallograft tissue 10 therein. The procurement extraction container 5 andthe extraction solution bottle 65 may each have an identifiercorresponding to one another.

In an embodiment, a barcode 80 may be provided on extraction solutionbottle 65 and procurement extraction container 5. Additional stickers orother preprinted labels with barcode 80 may be provided with a uniqueidentification number in the kit for procurement agency paperwork. In anembodiment, stickers with barcode 80 may be placed in the field ratherthan provided on extraction solution bottle 65 and procurementextraction container 5. This may be more efficient when multiple unitsof either extraction solution bottle 65 or procurement extractioncontainer 5 for a single donor.

With reference to FIG. 3, and in another embodiment, a flexible retainer85 may be configured to extend between screw cap 60 and connectorinterface 55. This provides an “all-in-one” solution in which the bag isa single item to minimize keeping track of a cap.

Although the above embodiments have been described in language that isspecific to certain structures, elements, compositions, andmethodological steps, it is to be understood that the technology definedin the appended claims is not necessarily limited to the specificstructures, elements, compositions and/or steps described. Rather, thespecific aspects and steps are described as forms of implementing theclaimed technology. Since many embodiments of the technology can bepracticed without departing from the spirit and scope of the invention,the invention resides in the claims hereinafter appended.

What is claimed is:
 1. A method of procuring an allograft tissue, themethod comprising: inserting an allograft tissue through a first openinginto a procurement extraction container; sealing the first opening ofthe procurement extraction container; adding an extraction fluid from anextraction solution bottle through a second opening into the procurementextraction container; wherein said second opening comprises both aconnector interface having both a set of outwardly disposed screwthreads configured to rotatable engage with the second closure deviceand a set of inwardly disposed screw threads configured to rotatablyengage with a set of outwardly disposed screw threads on the extractionsolution bottle; agitating the extraction fluid within the procurementextraction container; collecting the extraction fluid into theextraction solution bottle from the procurement extraction container fordetection of contamination; and sealing the second opening of theprocurement extraction container.
 2. The method of claim 1, wherein thestep of sealing the first opening includes forming a resealable sealwith a zip-lock closure.
 3. The method of claim 1, wherein the step ofsealing the first opening includes forming a non-resealable seal with aglue bar so as to provide a one-time closure.
 4. The method of claim 1,wherein the step of sealing the first opening includes forming a sealwith a zip-lock closure and subsequently forming a non-resealable sealwith a glue bar so as to provide a one-time closure.
 5. The method ofclaim 1, wherein the step of adding the extraction fluid includesattaching the procurement extraction container and the extractionsolution bottle to one another to form a hermetically sealed passagewayso as to provide movement of the extraction fluid in a controlled mannerbetween the extraction solution bottle and the procurement extractioncontainer.
 6. The method of claim 1, wherein the step of agitating theextraction fluid comprises shaking the procurement extraction containerso as to liberate bioburden into the extraction fluid.
 7. The method ofclaim 1, wherein the step of collecting the extraction fluid comprisesinverting the procurement extraction container to direct the extractionfluid into the extraction solution bottle.
 8. The method of claim 1,wherein the step of collecting the extraction fluid comprises attachinga screw cap to the extraction solution bottle for transportation priorto detection of contamination.
 9. The method of claim 1, wherein thestep of sealing the second opening includes attaching a screw cap on theprocurement extraction container.
 10. The method of claim 1, furthercomprising sending the procurement extraction container to a testinglaboratory, and sending the sealed bag to a tissue bank.
 11. A kit forprocurement of an allograft tissue, the kit comprising: an extractionsolution bottle having screw threads and a selectively removable caphaving screw threads corresponding to the screw threads of theextraction solution bottle; a procurement extraction containercomprising: at least one wall defining an interior sized to receive anallograft tissue; a first opening providing a first passageway betweenthe interior and an external environment, the first opening sized toreceive therethrough the allograft tissue from the external environmentinto the interior; a first closure device in operable connection withthe first opening, the first closure device providing a hermetic seal atthe first opening so as to provide, with the at least one wall, asterile barrier for procurement of the allograft tissue disposed withinthe interior; a second opening providing a second passageway between theinterior and the external environment, and the second opening having aconnector interface; and a second closure device in operable connectionwith the connector interface of the second opening, the second closuredevice providing a hermetic seal at the second opening so as to provide,with the first closure and the at least one wall, the sterile barrierfor procurement of the allograft tissue disposed within the interior;extraction fluid initially disposed in the extraction fluid bottle;wherein the extraction solution bottle and the procurement extractioncontainer selectively connect with one another to form a fluidconnection with a hermetic seal with one another to provide theextraction fluid to the procurement extraction container andsubsequently receive the extraction fluid from the container aftercontacting the allograft tissue disposed within the procurementextraction container; wherein said second opening comprises both aconnector interface having both a set of outwardly disposed screwthreads configured to rotatably engage with the second closure deviceand a set of inwardly disposed screw threads configured to rotatablyengage with a set of outwardly disposed screw threads on the extractionsolution bottle; and wherein each of the extraction solution bottle andthe procurement extraction container provide the sterile barrier forprocurement of the extraction fluid and the allograft tissue,respectively.
 12. The kit of claim 11, wherein the procurementextraction container is a flexible bag, wrapped around the extractionsolution bottle prior to insertion on the extraction bottle prior toinsertion of the allograft tissue therein.
 13. The kit of claim 12,wherein the procurement extraction container and the extraction solutionbottle each have an identifier corresponding to one another.
 14. The kitof claim 12, further comprising a flexible retainer extending betweenthe procurement extraction container and the second closure device.